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Safety & Effectiveness Requirements — Overview

What are the Safety and Effectiveness Requirements?​

Schedule 1 of the Medical Devices Regulations (SOR/98-282) sets out the Safety and Effectiveness Requirements that all medical devices sold in Canada must meet. These are the fundamental performance requirements that a manufacturer must demonstrate their device satisfies before a Device Licence can be issued.

They are equivalent to:

  • Essential Principles in Australia (TGA)
  • General Safety and Performance Requirements (GSPR) in the EU (MDR/IVDR Annex I)

The overarching principle​

The overarching requirement is that:

A device must be safe and effective when used as intended, and the benefits of the device must outweigh the risks associated with its use.

All more specific requirements flow from this principle.

Structure of Schedule 1​

Schedule 1 is organised into two broad groups:

Part 1 — General requirements (requirements that apply to all devices)

  • Design and construction to minimise risk
  • Benefit-risk balance
  • Durability and reliability
  • Devices that deliver energy or substances

Part 2 — Requirements for specific device types

  • Devices with a measuring function
  • Devices connected to or equipped with a source of ionising radiation
  • Devices incorporating software
  • Active implantable devices
  • Devices intended for sterilisation
  • Devices intended to be implanted in the body

Who must demonstrate compliance​

Compliance with Schedule 1 is required for all classes (I–IV), but the mechanism differs:

ClassHow compliance is demonstrated
Class IManufacturer self-declaration (not reviewed by Health Canada pre-market)
Class IIAttestation in Device Licence application + summary evidence
Class IIIDetailed pre-clinical and clinical evidence in Device Licence application
Class IVComprehensive evidence including clinical trials

Relationship to standards​

Health Canada maintains a list of recognised standards and mandatory standards that, when met, provide a presumption of compliance with specific Schedule 1 requirements. See Recognised & Mandatory Standards.

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 1